J Clin Nutr.  2019 Jun;11(1):5-11. 10.15747/jcn.2019.11.1.5.

Review of Worldwide Regulations and Management Systems for Medical Foods

Affiliations
  • 1MDwell Inc., Seoul, Korea.
  • 2Division of Pediatric Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. jm0815.seo@samsung.com

Abstract

Enteral nutrition (EN) formulas are foods that are used to improve the nutritional status of patients and these foods' safety and quality must be ensured. Therefore, EN formulas in other countries are managed differently from that of general foods. We investigated the direction of development of the relevant laws regulations and guidelines pertaining to EN formulas and we compared these laws regulations and guidelines from different countries, including Korea. The United States and Europe manage EN formulas as foods, but they are managed differently compared to general foods because of separate laws or programs pertaining to EN foods. In addition, the use of the formulas does not necessarily require a prescription, but when used by prescription, then medical insurance covers them. In Japan, there are two types of EN formulas, food and drug, and there are differences for their management and insurance coverage. In the case of Korea, EN formulas are classified as food and drug, and different management and insurance are applied in each case, which inhibits their systematic management and industrial development. Integration of a management system and establishment of a legal foundation is necessary for the systematic management and development of EN formula in Korea.

Keyword

Enteral nutrition; Regulation; Medical foods

MeSH Terms

Enteral Nutrition
Europe
Humans
Industrial Development
Insurance
Insurance Coverage
Japan
Jurisprudence
Korea
Nutritional Status
Prescriptions
Social Control, Formal*
United States
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